Catheter

Abstract

The invention relates to a catheter. The catheter comprises a base, a connecting tube and a balloon, one end of the connecting pipe is communicated with the base; one end of the balloon is connected with the end, away from the base, of the connecting pipe, the balloon is provided with a plurality of edges, the edges are distributed in the circumferential direction of the balloon at intervals, and the edges are used for cutting lesion plaques. According to the scheme provided by the invention, the operation risk and the production cost can be reduced.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to catheters. Background Art

[0002] Dilation of stenotic lesions is the cornerstone of current percutaneous coronary intervention (PCI) procedures, and more efficient dilation of complex lesions remains the most challenging topic in clinical research. Whether in Europe, the US, or the Asia-Pacific region, the use of balloon catheters for pre-dilation of lesions is a standard approach. Clinically, for complex lesions such as severe coronary artery stenosis and mildly calcified lesions, when conventional balloon technology still fails to guarantee lesion dilation and effective plaque rupture, novel balloon catheters with uneven surfaces are often a crucial technical tool, further reducing the likelihood of restenosis after dilation.

[0003] In related technologies, balloon catheters generally include cutting balloons, spinous balloons, double-guidewire balloons, and scored balloons. The microscopic blade design on the surface of the cutting balloon can reduce the incidence of balloon slippage, while the longitudinal cutting can more effectively remove diseased plaques along the blood vessel wall. Similar to the cutting balloon, the spinous balloon has nylon spines on its surface that can promote the formation of cracks in diseased plaques and prevent balloon slippage. The double-guidewire balloon has two guidewires distributed 180 degrees on the outside of the balloon, which can longitudinally tear plaques and improve the ability to pass tortuous lesions. The scored balloon has a spirally wound nickel-titanium alloy wire attached to the outside, which can obtain a larger initial lumen and reduce the rate of arterial restenosis.

[0004] Complex lesions, narrow and tortuous channels, and calcified plaques pose great challenges to surgeons. Although the above-mentioned balloons can improve the ability to remove plaques, their processing technology is complex, the cost is too high, and there is a risk of scratching blood vessels during the withdrawal process. Summary of the Invention

[0005] In order to solve or partially solve the problems existing in the related art, the present application provides a catheter that can reduce surgical risks and production costs.

[0006] In a first aspect, the present application provides a catheter comprising a base, a connecting tube, and a balloon; one end of the connecting tube is connected to the base; one end of the balloon is connected to an end of the connecting tube away from the base, and the balloon is provided with a plurality of edges, which are spaced apart along the circumference of the balloon, and are used to cut diseased plaques.

[0007] Furthermore, the catheter also includes an inner tube and an extension tube, the connecting tube is communicated with the balloon, the inner tube is located in the connecting tube and the balloon, the inner tube extends from one end of the balloon away from the connecting tube to the connecting tube and extends into the connecting tube, one end of the extension tube is connected to one end of the inner tube, and the extension tube extends outward from the inner tube through the connecting tube.

[0008] Furthermore, the outer circle of the cross section of the balloon is polygonal, the corners of the balloon constitute the edges, and the center of the cross section of the balloon is located on the central axis of the inner tube.

[0009] Furthermore, the outer circle of the balloon's cross section is polygonal, the corners of the balloon forming the edges, the center of the entire balloon's cross section is offset from the central axis of the inner tube, and the center of the inner circle of the balloon's cross section is located on the central axis of the connecting tube. Furthermore, the center of the inner circle of the balloon's cross section is offset from the central axis of the inner tube, and the thickness of one side of the balloon's cross section is greater than the thickness of the other side of the balloon's cross section.

[0010] Furthermore, the balloon includes a sphere, one end of the sphere is connected to the connecting tube, the edges are distributed at intervals along the circumference of the sphere, and the edges protrude outward from the sphere.

[0011] Furthermore, the edge is provided with notches at intervals along the extension direction of the connecting pipe.

[0012] Furthermore, the catheter further comprises a tip tube, one end of which is connected to an end of the balloon away from the connecting tube, and the tip tube is communicated with the inner tube, and the tip tube is located outside the balloon.

[0013] Furthermore, the catheter further includes a developing ring, which is located on the outer surface of the inner tube and inside the balloon.

[0014] Furthermore, the connecting tube includes an outer tube and a sea wave tube, one end of the sea wave tube is connected to the base, the end of the sea wave tube away from the base is connected to the outer tube, the end of the outer tube away from the sea wave tube is connected to the balloon, and the diameter of the outer tube is larger than the diameter of the sea wave tube.

[0015] The technical solution provided by this application may have the following beneficial effects: by providing a ridged edge on the balloon, the edge can be used to cut diseased plaques when the balloon is filled with saline. This edge replaces the blades on traditional catheters, eliminating the need for blades to cut diseased plaques. This prevents damage to the patient's blood vessels caused by the blades when the catheter is inserted into or withdrawn from the patient's blood vessels, improving surgical safety. The edge's excellent cutting performance and safety can significantly increase surgical success rates and reduce the risk of complications.

[0016] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The above and other objects, features and advantages of the present application will become more apparent by describing in more detail exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0018] Figure 1 1 is a schematic structural diagram of a catheter shown in an embodiment of the present application;

[0019] Figure 2 yes Figure 1 A partial enlarged view of

[0020] Figure 3 is a cross-sectional view of a hexagonal balloon shown in an embodiment of the present application;

[0021] Figure 4 is a cross-sectional view of an eccentric hexagonal balloon shown in an embodiment of the present application;

[0022] Figure 5 Schematic diagram of the structure of a dodecagonal balloon shown in an embodiment of the present application;

[0023] Figure 6 is a cross-sectional view of a dodecagonal balloon shown in an embodiment of the present application;

[0024] Figure 7 This is a schematic diagram of the structure of the OTW structural catheter;

[0025] Figure 8 yes Figure 7 sectional view of

[0026] Figure 9 is a schematic structural diagram of a catheter shown in another embodiment of the present application;

[0027] Figure 10 yes Figure 9Reference numerals: base 1; needle holder 11; stress relief tube 12; fluid channel 13; connecting channel 14; connecting tube 2; outer tube 21; hypotube 22; through hole 23; balloon 3; edge 31; notch 311; sphere 32; inner tube 4; extension tube 5; tip tube 6; developing ring 7. DETAILED DESCRIPTION

[0028] The following describes embodiments of the present application in more detail with reference to the accompanying drawings. Although the accompanying drawings illustrate embodiments of the present application, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0029] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0030] In the description of this application, it should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0031] Unless otherwise expressly specified or limited, the terms "mounted," "connected," "connect," "fixed," and the like should be interpreted broadly. For example, they may refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0032] In response to the above problems, an embodiment of the present application provides a catheter that can reduce surgical risks and production costs.

[0033] The technical solutions of the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0034] Figure 1 It is a schematic structural diagram of a catheter shown in an embodiment of the present application.

[0035] See also Figure 1 The catheter includes a base 1, a connecting tube 2, and a balloon 3. The base 1 can be inserted with a guide wire or filled with saline. One end of the connecting tube 2 is connected to the base 1, and the connecting tube 2 and the base 1 are in communication. When saline is poured into the base 1, the saline can pass through the base 1 and into the connecting tube 2.

[0036] Figure 2 yes Figure 1 A partial enlarged view of .

[0037] See also Figure 1-2 One end of the balloon 3 is connected to the end of the connecting tube 2 away from the base 1, and the balloon 3 and the connecting tube 2 are in communication, allowing saline solution to enter the balloon 3 through the connecting tube 2. The balloon 3 is made of a relatively hard polymer material, such as nylon, and is used to dilate blood vessels and incise diseased plaques. The balloon 3 is provided with a plurality of edges 31, which are spaced apart along the circumference of the balloon 3. After the balloon 3 is inserted into a blood vessel and filled with saline solution, the balloon 3 expands into a structure similar to a prism with a polygonal cross-section. The balloon 3 can then prop open and dilate the blood vessel, while the relatively hard edges 31 can be used in place of blades to incise diseased plaques on the inner wall of the blood vessel.

[0038] The present application provides an edge 31 on the balloon 3. When the balloon 3 is filled with physiological saline, the edge 31 can be used to cut the diseased plaque, and the edge 31 replaces the blade on the traditional catheter. There is no need to use a blade to cut the diseased plaque, which avoids the blade from damaging the patient's blood vessel when the catheter is inserted into the patient's blood vessel or retracted from the blood vessel, thereby improving the safety of the operation. The edge 31 has excellent cutting performance and safety, which can greatly improve the success rate of the operation and reduce the risk of complications.

[0039] See also Figure 1-2 In some embodiments, the catheter has an RX structure. The catheter further includes an inner tube 4 and an extension tube 5. A portion of the inner tube 4 is within the connecting tube 2, and a portion of the inner tube 4 is within the balloon 3. Specifically, the inner tube 4 extends from the end of the balloon 3 away from the connecting tube 2 toward the connecting tube 2 and into the connecting tube 2. One end of the extension tube 5 is connected to the end of the inner tube 4 away from the balloon 3, and the extension tube 5 is in communication with the inner tube 4. The extension tube 5 extends outward from the inner tube 4 through the connecting tube 2. A guide wire can be inserted into the extension tube 5 and the inner tube 4. When a guide wire is needed, the guide wire can pass through the connecting tube 2 and extend into the inner tube 4. When saline is injected into the connecting tube 2 and the balloon 3, the saline will not enter the inner tube 4 and the extension tube 5.

[0040] Figure 7 This is a schematic diagram of the structure of the OTW structural catheter; Figure 8 yes Figure 7 sectional view of .

[0041] See also Figure 7-8 In some embodiments, the catheter can have an OTW structure. The catheter also includes an inner tube 4, one end of which extends into the balloon 3 and the other end of which is connected to the base 1. The base 1 is provided with a fluid channel 13 and a connecting channel 14, which is connected to one end of the inner tube 4. The connecting channel 14 is connected to one end of the inner tube 4. The connecting tube 2 is sleeved outside the inner tube 4 and is connected to the fluid channel 13. When the balloon 3 needs to be expanded, physiological saline can be injected into the fluid channel 13. The physiological saline flows along the fluid channel 13 into the channel between the connecting tube 2 and the inner tube 4, then flows into the space between the balloon 3 and the inner tube 4, and the physiological saline gradually expands the balloon 3.

[0042] See also Figure 2 The catheter also includes a tip tube 6, one end of which is connected to the end of the balloon 3 away from the connecting tube 2, and the tip tube 6 is connected to the inner tube 4. The tip tube 6 is located outside the balloon 3, and the outer diameter of the tip tube 6 gradually decreases from the inner tube 4 to the direction away from the balloon 3. The tip tube 6 can provide a transition section when the balloon 3 is extended into the blood vessel, making it easier for the tip tube 6 to pass through the blood vessel.

[0043] See also Figure 2 The catheter also includes a developing ring 7, which is located on the outer surface of the inner tube 4 and inside the balloon 3. The developing ring 7 can be used as a position mark when the patient takes an X-ray. In some embodiments, there are two developing rings 7, and the balloon 3 has two shoulders, one of which is a section of an inclined surface of the balloon 3 from the end point farthest from the inner tube 4 to the connection between the balloon 3 and the connecting tube 2, and the other is a section of an inclined surface of the balloon 3 from the end point farthest from the inner tube 4 to the connection between the balloon 3 and the tip tube 6. The shoulder of the balloon 3 and the developing ring 7 are on the same radial line of the inner tube 4, and the two developing rings 7 correspond one-to-one to the two shoulders of the balloon 3. When the patient takes an X-ray, the specific position of the balloon 3 can be understood by sensing the positions of the two developing rings 7.

[0044] See also Figure 1The connecting tube 2 includes an outer tube 21 and a hypotube 22. One end of the hypotube 22 is connected to the base 1, and the end of the hypotube 22 away from the base 1 is connected to the outer tube 21. The end of the outer tube 21 away from the hypotube 22 is connected to the balloon 3. The diameter of the outer tube 21 is larger than the diameter of the hypotube 22. The hypotube 22 is made of stainless steel. The hypotube 22 can provide structural strength support for the extension of the catheter in the blood vessel. The hypotube 22 is connected to the base 1 to provide an independent pressure expansion channel for the distal balloon 3. The outer tube 21 is made of a high molecular polymer material. The outer tube 21 is overlapped on the outer surface of the hypotube 22 and acts as a transition part to convey pressure. The pins of the balloon 3 are fixed on the outer surface of the outer tube 21. After the expansion is expanded by injecting physiological saline from the base 1, a structure with a polygonal cross section is formed.

[0045] See also Figure 1 The base 1 includes a needle seat 11 and a stress relief tube 12. The needle seat 11 is connected to the hypotube 22. The needle seat 11 is provided with an inner cavity, which is connected to the hypotube 22. The stress relief tube 12 is sleeved outside the hypotube 22 and is connected to the needle seat 11. The stress relief tube 12 can reduce the stress on the needle seat 11 when the hypotube 22 turns, thereby ensuring that the needle seat 11 and the hypotube 22 are firmly connected.

[0046] In some embodiments, the outer circle of the cross section of the balloon 3 can be a polygon. For example, the outer circle of the cross section of the balloon 3 can be a quadrilateral, a hexagon, an octagon, a dodecagon, etc. The more edges 31 the balloon 3 has, the larger the cutting range, the fewer edges 31 the balloon 3 has, the sharper the edges 31, and the stronger the cutting strength. During the production process of the balloon 3, a polygonal mold can be used to process the blastocyst during the blow molding process of the balloon 3. The formed balloon 3 inherits the characteristics of the polygon, and the strong edges 31 of the balloon 3 can replace the cutting blade to effectively cut the diseased plaque. Preferably, the inner circle of the cross section of the balloon 3 is circular. This application takes the embodiment of the balloon 3 having a hexagonal or dodecagonal cross section as an example, and the examples of balloons 3 with other numbers of edges 31 are not repeated.

[0047] Figure 3 It is a cross-sectional view of the hexagonal balloon shown in an embodiment of the present application.

[0048] See also Figure 1-3In some embodiments, the outer circle of the cross-section of the balloon 3 is a regular hexagon, the thickness of the cross-section of the balloon 3 is substantially uniform at all locations, and the balloon 3 is provided with six edges 31. The center of the cross-section of the balloon 3 is located on the central axis of the outer tube 21, and the center of the cross-section of the balloon 3 is located on the central axis of the inner tube 4. The catheter formed by this embodiment can achieve rapid advancement of the balloon 3 to the lesion site and utilize the edges 31 to cut the lesion plaque. Since no additional blade is required, compared to traditional catheters, the production cost is reduced, the success rate of the operation is improved, and the risk of complications is reduced. Moreover, since the cross-section of the balloon 3 is a symmetrical structure, the expansion of the blood vessel after the balloon 3 is expanded is relatively uniform, avoiding the risk of excessive expansion of the blood vessel due to secondary expansion. Compared with the dodecagonal balloon 3, the edges 31 of the balloon 3 of this embodiment are sharper, and the cutting strength of the plaque is stronger.

[0049] In some embodiments, the outer circle of the cross-section of the balloon 3 is a regular hexagon, the thickness of the cross-section of the balloon 3 is substantially uniform throughout, and the balloon 3 is provided with six edges 31. The center of the inner circle of the cross-section of the balloon 3 is offset from the central axis of the inner tube 4, the center of the outer circle of the cross-section of the balloon 3 is offset from the central axis of the inner tube 4, and the center of the cross-section of the balloon 3 is located on the central axis of the outer tube 21. The catheter formed in this embodiment enables rapid advancement of the balloon 3 to the lesion site and utilizes the edges 31 to cut the lesion plaque, reducing production costs, improving the success rate of the procedure, and lowering the risk of complications. After expansion, the balloon 3 can form a structure that is eccentric relative to the central axis of the inner tube 4, enabling better blood circulation and better treatment of eccentric stenosis.

[0050] Figure 4 It is a cross-sectional view of an eccentric hexagonal balloon shown in an embodiment of the present application.

[0051] See also Figure 1 and Figure 4 In some embodiments, the outer circle of the cross-section of the balloon 3 is a regular hexagon, and the thickness of the cross-section of the balloon 3 is not uniform across the cross-section. The balloon 3 is provided with six edges 31, and the center of the overall cross-section of the balloon 3 is offset from the central axis of the inner tube 4. Specifically, the center of the outer circle of the cross-section of the balloon 3 is on the central axis of the inner tube 4, and the center of the inner circle of the cross-section of the balloon 3 is offset from the central axis of the inner tube 4. The center of the inner circle of the cross-section of the balloon 3 is on the central axis of the outer tube 21, and the thickness of one side of the cross-section of the balloon 3 is greater than the thickness of the other side of the cross-section of the balloon 3. The catheter formed in this embodiment can achieve rapid advancement of the balloon 3 to the lesion site and utilize the edges 31 to cut the lesion plaque, reducing production costs, while improving the success rate of the surgery and reducing the risk of complications. After inflation, the balloon 3 can form a structure that is eccentric relative to the central axis of the inner tube 4, which can improve blood circulation and better address eccentric stenosis.

[0052] Figure 5Schematic diagram of the structure of a dodecagonal balloon shown in an embodiment of the present application; Figure 6 This is a cross-sectional view of a dodecagonal balloon shown in an embodiment of the present application.

[0053] See also Figure 5-6 In some embodiments, the outer circle of the cross-section of the balloon 3 is a regular dodecagon, and the balloon 3 has twelve edges 31. The center of the cross-section of the balloon 3 is located on the central axis of the connecting tube 2. The center of the cross-section of the balloon 3 may be located on the central axis of the inner tube 4, or it may not be located on the central axis of the inner tube 4. The catheter formed by this embodiment can achieve rapid advancement of the balloon 3 to the lesion site and utilize the edges 31 to cut the lesion plaque, reducing production costs, improving the success rate of the surgery, and reducing the risk of complications. Compared with a balloon 3 with six edges 31, the twelve edges 31 have more edges 31, which can effectively increase the cutting range of the balloon 3 on the plaque.

[0054] Figure 9 is a schematic structural diagram of a catheter shown in another embodiment of the present application; Figure 10 yes Figure 9 sectional view of .

[0055] See also Figure 9-10 In some embodiments, the balloon 3 includes a sphere 32, which is integrally formed with edges. One end of the sphere 32 is connected to the connecting tube 2. The edges 31 are spaced apart along the circumference of the sphere 32. The cross-section of the sphere 32 is circular, and the edges 31 protrude outward from the sphere 32. When the number of edges 31 is less than four, since the balloon 3 requires a certain volume without the edges 31, the balloon 3 is designed to have a shape that combines the sphere 32 with the edges 31, which can reduce the space occupied by the balloon 3. This structure is suitable for catheters with OTW structures and RX structures. Preferably, the edges 31 are provided with notches 311 at intervals along the extension direction of the inner tube 4. By forming the notches 311 on the edges 31, a single edge 31 is divided into multiple sections, thereby improving the conductivity of the balloon 3 in the blood vessel.

[0056] The scheme of the present application has been described in detail above with reference to the accompanying drawings. In the above embodiments, the descriptions of each embodiment have their own emphasis. For parts that are not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments. Those skilled in the art should also be aware that the actions and modules involved in the description are not necessarily required for this application. In addition, it is understood that the steps in the method of the embodiment of the present application can be adjusted in sequence, merged and deleted according to actual needs, and the modules in the device of the embodiment of the present application can be merged, divided and deleted according to actual needs.

[0057] The embodiments of the present application have been described above. The above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to the technology in the market, or to enable other persons skilled in the art to understand the embodiments disclosed herein.

Claims

1. A catheter, characterized in that: include: base; a connecting pipe, one end of which is connected to the base; A balloon, one end of which is connected to the end of the connecting tube away from the base, the balloon is provided with a plurality of edges, the edges are distributed at intervals along the circumference of the balloon, and the edges are used to cut the diseased plaque.

2. The catheter according to claim 1, wherein: It also includes an inner tube and an extension tube, the connecting tube is communicated with the balloon, the inner tube is located in the connecting tube and the balloon, the inner tube extends from one end of the balloon away from the connecting tube to the connecting tube and extends into the connecting tube, one end of the extension tube is connected to one end of the inner tube, and the extension tube extends outward from the inner tube through the connecting tube.

3. The catheter according to claim 2, wherein: The outer circle of the cross section of the balloon is polygonal, the corners of the balloon constitute the edges, and the center of the cross section of the balloon is located on the central axis of the inner tube.

4. The catheter according to claim 2, wherein: The outer circle of the cross section of the balloon is polygonal, the corners of the balloon constitute the edges, the center of the entire cross section of the balloon is staggered with the central axis of the inner tube, and the center of the inner circle of the cross section of the balloon is located on the central axis of the connecting tube.

5. The catheter according to claim 4, characterized in that: The center of the inner circle of the cross section of the balloon is staggered from the central axis of the inner tube, and the thickness of one side of the cross section of the balloon is greater than the thickness of the other side of the cross section of the balloon.

6. The catheter according to claim 1 or 2, characterized in that: The balloon includes a sphere, one end of the sphere is connected to the connecting tube, the edges are distributed at intervals along the circumference of the sphere, and the edges protrude outward from the sphere.

7. The catheter according to claim 6, characterized in that: The edge is provided with notches at intervals along the extending direction of the connecting pipe.

8. The catheter according to claim 2, wherein: It also includes a tip tube, one end of which is connected to the end of the balloon away from the connecting tube, and the tip tube is connected to the inner tube, and the tip tube is located outside the balloon.

9. The catheter according to claim 2, wherein: It also includes a developing ring, which is located on the outer surface of the inner tube and inside the balloon.

10. The catheter according to claim 1, wherein: The connecting tube includes an outer tube and a hypotube, one end of the hypotube is connected to the base, the end of the hypotube away from the base is connected to the outer tube, the end of the outer tube away from the hypotube is connected to the balloon, and the diameter of the outer tube is larger than the diameter of the hypotube.

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